Multi-centre randomised controlled trial of ion-exchange water softeners for the treatment of atopic eczema in children (Softened Water Eczema Trial)

Difference between the active vs. standard treatment groups with regard to mean change in disease severity (SASSAD 5) at 12 weeks compared to baseline. SASSAD is an objective severity scale that is completed by the research nurse during follow-up appointments. It does not involve input from the patient in any way.

Current information as of 14/01/10:
1. Difference between the groups in the proportion of time spent moving during the night . Movement will be captured for periods of one week at week 1 and week 12 and will be measured using accelerometers (Actiwatch™). These units are worn by the child in the same way as a wrist watch. This outcome has been included as an objective surrogate for sleep loss and itchiness (two of the defining features of eczema). Previous research has suggested that this is a suitable objective tool for assessing itch and further pilot work is currently underway to assess its suitability for use within this trial.
2. Difference in those who report a reasonable (≤20%), good (>20% and ≤50%) or excellent (>50%) improvement in SASSAD score at 12 weeks.
3. Difference in Patient Oriented Eczema Measure (POEM) collected at baseline, weeks 4, 12 and 16. This scale is a well validated tool that has been developed to capture symptoms of importance to patients (rather than objective signs that are used in traditional severity scales, such as SASSAD).
4. Difference in the number of totally controlled weeks (TCW) and well controlled weeks (WCW) based on the number of days with eczema symptoms and the number of days that topical treatment is applied, up to the primary endpoint at 12 weeks. This outcome is based on a recent systematic review conducted by the applicants looking at ways of assessing long-term control for chronic conditions such as atopic eczema, asthma and rheumatoid arthritis. The terms TCW and WCW have been adopted for use by researchers in the field of asthma and appear to be a useful and intuitive means of capturing disease activity over time.
5. Difference in the mean change in the Dermatitis Family Impact (DFI) questionnaire at 12 weeks. This scale was chosen as an appropriate quality of life scale for the study for two reasons:
a. The intervention involves the entire household, so a quality of life scale appropriate to the family unit seems most appropriate
b. It avoids the need to use two different age-specific dermatology quality of life scales (the Children’s Dermatology Life Quality Index and the Infants version of the same scale)
6. Mean change in health related Quality of Life at 12 weeks. This will be captured using a generic measure of health utility (the children’s version of the EQ-5D for children aged 7 years and over, or the proxy version of the EQ-5D for children aged 3 to 6 years.
7. Difference in the amount of topical corticosteroid / calcineurin inhibitors used up to the primary endpoint at 12 weeks.

Initial information at time of registration:
1. Difference between the groups in the proportion of time spent moving during the night . Movement will be captured for periods of one week at week 1 and week 12 and will be measured using accelerometers (Actiwatch™). These units are worn by the child in the same way as a wrist watch. This outcome has been included as an objective surrogate for sleep loss and itchiness (two of the defining features of eczema). Previous research has suggested that this is a suitable objective tool for assessing itch and further pilot work is currently underway to assess its suitability for use within this trial.
2. Difference in proportion of children who report either good or excellent improvement in eczema severity at 12 weeks (using a 5-point Likert scale).
3. Difference in Patient Oriented Eczema Measure (POEM) collected at baseline, weeks 4, 12 and 16. This scale is a well validated tool that has been developed to capture symptoms of importance to patients (rather than objective signs that are used in traditional severity scales, such as SASSAD).
4. Difference in the number of totally controlled weeks (TCW) and well controlled weeks (WCW) based on the number of days with eczema symptoms and the number of days that topical treatment is applied. This outcome is based on a recent systematic review conducted by the applicants looking at ways of assessing long-term control for chronic conditions such as atopic eczema, asthma and rheumatoid arthritis. The terms TCW and WCW have been adopted for use by researchers in the field of asthma and appear to be a useful and intuitive means of capturing disease activity over time.
5. Difference in the mean change in the Dermatitis Family Impact (DFI) questionnaire at 12 weeks. This scale was chosen as an appropriate quality of life scale for the study for two reasons:
a. The intervention involves the entire household, so a quality of life scale appropriate to the family unit seems most appropriate
b. It avoids the need to use two different age-specific dermatology quality of life scales (the Children’s Dermatology Life Quality Index and the Infants version of the same scale)
6. Mean change in health related Quality of Life at 12 weeks. This will be captured using a generic measure of health utility (the children’s version of the EQ-5D for children aged 7 years and over, or the proxy version of the EQ-5D for children aged 3 to 7 years.